UROVIEW II

System, X-ray, Fluoroscopic, Image-intensified

OEC-DIASONICS, INC.

The following data is part of a premarket notification filed by Oec-diasonics, Inc. with the FDA for Uroview Ii.

Pre-market Notification Details

Device IDK893475
510k NumberK893475
Device Name:UROVIEW II
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant OEC-DIASONICS, INC. 2341 SOUTH 2300 WEST P.O. BOX 25296 Salt Lake City,  UT  84119
ContactJohn W Tolhurst
CorrespondentJohn W Tolhurst
OEC-DIASONICS, INC. 2341 SOUTH 2300 WEST P.O. BOX 25296 Salt Lake City,  UT  84119
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-04
Decision Date1989-08-10

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